BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOTRAC SENSOR

    MDR report key: 16553293 · Received March 16, 2023

    Report

    Report Number
    2015691-2023-11507
    Event Type
    Malfunction
    Date Received
    March 16, 2023
    Report Date
    March 16, 2023
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DRS
    PMA / PMN Number
    K043065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT RETURN OF THE UNIT IT IS NOT POSSIBLE TO DETERMINE IF SOME DAMAGE OR DEFECT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. IT IS NOT KNOWN IF SOME PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. FURTHER EVALUATION REGARDING RELATED QUALITY ISSUES IS UNDER INVESTIGATION. THE LOT NUMBER WAS NOT PROVIDED THUS A DEVICE HISTORY RECORD WAS NOT REVIEWED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS OBTAINED THROUGH A LITERATURE PUBLISHED IN SCIENTIFIC REPORTS, AGREEMENT BETWEEN CONTINUOUS CARDIAC OUTPUT MEASURED BY THE FOURTH GENERATION FLOTRAC VIGILEO SYSTEM AND A PULMONARY ARTERY CATHETER IN ADULT LIVER TRANSPLANTATION. IN LIVER TRANSPLANTATION FOR END STAGE LIVER FAILURE, MONITORING OF CONTINUOUS CARDIAC OUTPUT, CCO IS USED FOR CIRCULATORY MANAGEMENT DUE TO HEMODYNAMIC INSTABILITY. CCO IS OFTEN MEASURED USING THE MINIMALLY INVASIVE FLOTRAC VIGILEO SYSTEM, FVS CCO, INSTEAD OF A HIGHLY INVASIVE PULMONARY ARTERY CATHETER, PAC CCO. THE FVS HAS IMPROVED ACCURACY DUE TO AN UPDATED CARDIAC OUTPUT ALGORITHM, BUT THE EFFECT OF THIS CHANGE ON THE ACCURACY OF FVS CCO IN LIVER TRANSPLANTATION IS UNCLEAR. IN THIS STUDY, WE ASSESSED AGREEMENT BETWEEN FOURTH GENERATION FVS CCO AND PAC CCO IN 20 PATIENTS AGED GREATER OR EQUAL TO 20 YEARS WHO UNDERWENT SCHEDULED OR EMERGENCY LIVER TRANSPLANTATION AT KYOTO UNIVERSITY HOSPITAL FROM SEPTEMBER 2019 TO JUNE 2021. CONSENT WAS OBTAINED BEFORE SURGERY AND DATA WERE RECORDED THROUGHOUT THE SURGICAL PERIOD. PEARSON CORRELATION COEFFICIENT, R, BLAND ALTMAN AND 4 QUADRANT PLOT ANALYSES WERE PERFORMED ON THE EXTRACTED DATA. A TOTAL OF 1517 PAC CCO VS. FVSCCO DATA PAIRS WERE OBTAINED. THE MEAN PAC CCO WAS 8.73 L OVER MIN, AND THE MEAN SYSTEMIC VASCULAR RESISTANCE WAS 617.5 DYNE S CM5, R WAS 0.48, BIAS WAS 1.62 L OVER MIN, THE 95 PERCENTAGE LIMITS OF AGREEMENT WERE NEGATIVE 3.04 TO 6.27, AND THE PERCENTAGE ERROR WAS 54.36 PERCENT. THESE RESULTS SHOW THAT AGREEMENT AND TRENDING BETWEEN FOURTH GENERATION FVS CCO AND PAC CCO ARE LOW IN ADULT LIVER TRANSPLANT RECIPIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437374 FLOTRAC SENSOR TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR DRS EDWARDS LIFESCIENCES DR FLOTRACUNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown